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Cost-effective Stability Program to Support Global Supply Chain of Drug Products
Wednesday, November 14
9:00 am – 11:00 am
Roundtable
ACPE #073-999-07-523-L04
Short-term temperature excursions during shipment could have an impact on the quality and stability of drug products. Recently, authorities introduced guidelines for temperature control of drug products during storage and transportation. In addition, GMP requirements force manufacturers to pay more attention to the maintenance of the desired state of quality throughout the supply chain. Temperature monitoring tools are available to control and document what happened during shipment. A meaningful evaluation of the data found is essential in order to assess the risk of using products that have been exposed to extreme temperatures during shipment. A cost-effective stability testing design and temperature monitoring program will be proposed that will enable manufacturers to reduce the amount of testing without increasing the risk of failures – balancing the need to reduce the costs of goods with the need to provide stable products to all patients concerned.
Moderator
Manuel Zahn, Ph.D.
AstraZeneca
A Risk-based Approach to Assess the Quality of Products That Have Been Exposed to Extreme Temperatures During Shipment
Manuel Zahn, Ph.D.
AstraZeneca
Temperature Monitoring of Sensitive Products During Shipment and Storage – Regulatory Requirements
Karen A. Russo, Ph.D.
U.S. Pharmacopeia
Shipping Around the World: Global Stability Testing Program to Support the Supply Chain – Industry Experience
Peter Karlton
Gilead Sciences, Inc.